MAUDE Adverse Event Report: COOK INC ANGLED TIP URETERAL CATHETER; GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY

Model Number	N/A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/31/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The event is currently under investigation.A follow up report will be send upon conclusion.
Event or Problem Description
It was reported by the user facility that a patient underwent a cholecystectomy laparoscopy with ioc procedure.The surgery staff has reported that they have come across a defective angled tip ureteral catheter set prior to patient contact.The staff reported that the small cap on the end is not attached and is only loose in the packaging.However, the procedure was completed with a different catheter and no additional procedures or adverse effects to the patient were warrant due to this occurrence.No further information was provided.
Additional Manufacturer Narrative
Investigation ¿ evaluation: the angled tip ureteral catheter was not returned for evaluation and no photos have been provided.Without the complaint device, a physical investigation was not able to be completed.There is no indication that a design or process related failure mode contributed to this event.A review of production and quality documentation did not identify any specific issues with current manufacturing or quality controls that may have contributed to this incident.The device history record was reviewed and no non-conformances were noted that would have caused or contributed to the reported issue.A review of complaint history for this product/lot number combination revealed one other complaint associated with complaint lot number 7367362.This other complaint was for the same problem and reported by the same customer.Based on the investigation evaluation the root is likely to be manufacturing process related.Per the quality engineering risk assessment, no further action is required.Cook medical has notified the appropriate personnel and will continue to monitor this device via the complaints database for similar complaints.

• Brand Name: ANGLED TIP URETERAL CATHETER
• Common Device Name: GBL CATHETER, URETERAL, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 6525781
• Report Number: 1820334-2017-00724
• Device Sequence Number: 1269360
• Product Code: GBL
• UDI-Device Identifier: 00827002145986
• UDI-Public: (01)00827002145986(17)191018(10)7367362
• Combination Product (Y/N): N
• Initial Reporter State: WY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/28/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 023105
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/29/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 04/27/2017
• Supplement Report FDA Received Date: 09/28/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1